TriloTalk Episode 21 Website Thumbnail (1)
Episode 21: Pen to Paper: Insights on Recognizing, Addressing, and Avoiding Medical Writer Burnout
TriloTalk Episode 20 Website Thumbnail
Episode 20: Q&A With Trilotalk: Focus on General Medical Writing Principles 
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AI for Medical Writers – Friend or Foe?
Lisa Chamberlain James and Jamie Norman
Journal for Clinical Studies
September 2023
Artificial Intelligence (AI) is beginning to affect almost every industry, and medical writing is no different. But how does this relate to our industry? How will AI affect medical writers? What’s already available and what is in the pipeline? Should medical writers be happy and embrace the technology, or should we resist as much as we can, assuming that we will all be replaced by machines? This article discusses the current state of the art of AI in medical writing and asks the question: AI for medical writers – friend or foe?
TriloTalk Episode 19 Website Thumbnail (2)
Episode 19: Elevating the voice of patients: the role of medical writers in making a difference
Clinical study protocol_Julia Forjanic Klapproth_Trilogy Writing
How well-written clinical study protocols get drugs to patients faster
Julia Forjanic Klapproth
Clinical Trials Insight
July 2023
In the world of drug development and approval, time is of the essence. But beginning the process with a poorly written protocol will only impede teams before a study has even begun. Julia Forjanic Klapproth, co-founder of Trilogy Writing & Consulting, describes how a well-written protocol will help patients receive their treatments sooner rather than later.
TriloTalk Episode 18 Website Thumbnail (2)
Episode 18: Clinical Study Protocol Development from a Writer's Perspective
Episode 17
Episode 17: The Importance of Training Medical Writing Leaders
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Episode 16: AI for Medical Writing - Turkeys Voting for Christmas?
Spotlight on Briefing Books
Episode 15: How to Streamline Regulatory Authority Meetings: Spotlight on Briefing Books
The Importance of Getting Clinical Study Protocols Right
Episode 14: The Importance of Getting Clinical Protocols Right
Clinical Study Protocols
Clinical Study Protocols: The Pillars of Clinical Development
Medical Writing Supplement of International Clinical Trials, ICT
February 2023
AMWA Journal Winter Cover 2022
The Future of Medical Writing: A Panel of One
Lisa Chamberlain James
AMWA Journal
December 2022
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Episode 13: Q&A with TriloTalk: Focus on CSRs
Think-TankTrabsparency-landscape-January-2019-NC-1
Navigating the Global Transparency Landscape
Medical Writing 31-3
Remote meetings made easy: Good practices to keep in mind
Tiago Silva, Catarina Silva, Tiago Campos, Maria Mascarenhas
Medical Writing Volume 31, Issue 3
2022
ICT Front Cover
Strategic Benefits
Julia Forjanic Klapproth
ICT Medical Writing
Nov 2011
Episode-12-Thumbnail
Episode 12: PIF and PIF Tick. What are these and why are they important?
September 2022
Think-Tank-October-2019-Massachusetts-
Taming the Complexity of Preparing CTD Submission Dossiers: Science meets Logistics
Think-Tank-Date-Januay-london-25Oct
Writing Lay Summaries
TriloTakes
TriloTake on Lay Summaries
11_05_2020-Think-Tank-Lay-Summaries-Past-Event
Writing Lay Summaries
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Episode 11: Taming the Complexity of Preparing CTD Submission Dossiers
July 2022
Process optimization, effective management, and organisation strategies are all essential components when preparing CTD submission dossiers for drug approval.
ICT-May-2022
How to Streamline Regulatory Authority Meetings
Maria Mascarenhas and Barry Drees
International Clinical Trials
May 2022
Streamlining meetings with regulatory authorities is a continually evolving process. But what role do briefing documents play, and what is the best way to produce these effectively?
The Importance of Style Guides
Episode 10: The Importance of Style Guides
June 2022
The Ethics of Medical Writing
Episode 9: The Ethics of Medical Writing
May 2022
Responses to Regulatory Authorities
Episode 8: Responses to Regulatory Authorities
April 2022
A Primer for Writing Oncology Dossiers
Episode 7: A Primer for Writing Oncology Dossiers
March 2022
Apprenticing Medical Writers
Episode 6: Apprenticing Medical Writers
February 2022
Cover-Picture-OCT-handbook-2021
Artificial intelligence for medical writing, part two: transparency, flexibility and control
Barry Drees
Outsourcing in Clinical Trials Handbook 2022
December 2021
In an earlier article about artificial intelligence (AI) for medical writing1, I stressed that AI tools would assist, accelerate and augment the process of clinical documentation. I also argued that the key to the third aspect, augmentation, was the use and future acceptance of standard texts.
OCT-2022-Cover-Page
How to streamline a complex process: why experienced medical writers will add value to oncology dossiers
Julia Forjanic Klapproth and Maurice Löwens
Clinical Operations in Oncology Trials Handbook 2022
December 2021
Lay Summaries
Episode 5: Lay Summaries
January 2022
The Power of Good Review Practice
Episode 4: The Power of Good Review Practice
December 2021
ICT-Cover-Page-November-Edition
The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers
Douglas Fiebig
International Clinical Trials
November 2021
While the ICH’s Common Technical Document (CTD) is an internationally agreed format for preparing application dossiers needed for obtaining approval to market a drug, the ensuing review process is specific to the country or region in question. Irrespective of the differences in process between countries and regions, questions will almost always be issued during the review process, with a request for written responses.
Journal-for-Clinical-Studies-Volumne-13-edition-5
Plain Language Summaries of Publications – what has COVID-19 taught us?
Lisa Chamberlain James and Rachel Beeby
Journal for Clinical Studies
October 2021
The COVID-19 pandemic has significantly impacted the whole world and the public has had to struggle with understanding scientific data on a daily basis. The impact of scientific misunderstanding became painfully apparent with the decline in vaccine uptake and so the need for clear, understandable scientific information has never been more vital.
The Value of Medical Writing
Episode 3: The Value of Medical Writing
November 2021
The Role of AI in Medical Writing
Episode 2: The Role of AI in Medical Writing
October 2021
Lead Medical Writing
Episode 1: Lean Medical Writing
September 2021
H1-Journal-Front-Page
Reaping the Benefits from Improved Clinical Study Protocols
Julia Forjanic Klapproth
H1 Virtual Events: Review and Summary Handbook
June 2021
Clinical study protocols are important cornerstones on the journey of collecting the clinical data needed to elucidate the benefit-risk profile of medical treatments/devices. Not only do they lay down the plan for the study at hand, they serve as a repository of knowledge for the strategic intentions and will be used for multiple down-stream activities. They are the basis for trial registration, provide guidance to those running the study, and will be used by participants, ethics committees/institutional review boards, funders, regulators, journal editors, and systematic reviewers to appraise the study.
Clinical-Trials-Insight-July-2021
Lean Medical Writing: Story not Storage
Barry Drees
Clinical Trials Insight
June 2021
The most difficult task an author can face is clearly summarising a complex and data-filled clinical regulatory document and explaining the data. Barry Drees, co-founder and senior partner of Trilogy Writing & Consulting, discusses the recent concept of ‘lean medical writing’ (LMW), and how it is being implemented and used in the pharmaceutical industry.
JCS-Summer-2021
Communicating with Patients. Who and How?
Lisa Chamberlain James
Journal for Clinical Studies
June 2021
Despite the fact that patient-friendly versions of many regulatory documents are now mandated by the regulations, the most frequently encountered reaction to communicating patient information is apathy.
Think-tank-past-event-web-15Dec
Taming the Complexity of Preparing CTD Submission Dossiers: Science Meets Logistics
Trilogy hosted its second virtual Think Tank on how to make the process of writing and coordinating a CTD submission dossier as efficient as possible and, ultimately, reduce the stress often associated with this activity.
EPC Journal
The Clinical Development Plan – The Importance of Getting it Right
Barry Drees and Julia Forjanic Klapproth
European Pharmaceutical Contractor, EPC
November 2020
Given the extreme complexity and difficulty of developing new pharmaceutical products, one would think that the planning for such an endeavour would be taken very seriously. Yet, somewhat surprisingly, it frequently is not.
OCT-Handbook-2021
AI for Medical Writing: Assistance, Acceleration and Augmentation
Barry Drees
Outsourcing in Clinical Trials Handbook 2021
October 2020
Regulatory-Rapporteur-Article-67-Cover
Do We Need to Involve Patients in Clinical Study Report Lay Summaries?
Lisa Chamberlain James and Barry Drees
Regulatory Rapporteur
Vol. 17, Issue 9, September 2020
Translating complex clinical regulatory documents into versions that are understandable to patients and the general public was never going to be an easy task, but it is a very necessary, important, and now legally mandated one. This article argues that the advent of the clinical trial results lay summary requirement has highlighted the need for patient involvement in clinical trials at the very earliest stages.
Clinical-Trials-Insight-Cover-Summer-2020
Assistance, Acceleration and Augmentation
Barry Drees
Clinical Trials Insight
Summer 2020
ICT-Magazine-The-Future-Awaits-Us-Article-May-2020
The Future Awaits Us
Barry Drees
European Pharmaceutical Contractor, EPC
May 2020
Medical-Device-Developments-2020_Vol.1-Cover
The Clinical Evaluation Report: Document Writing and Compilation
Gerard McGregor
Medical Device Developments
2020, Volume 1
Medical-Writing-Special-Edition-2-Front-Cover
Help Reviewers Tell You What They Want
Diana Radovan
Medical Writing Special Edition No. 2
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Writing for Patients: When and How
Lisa Chamberlain James, Deborah Collyar, Allen Todd, Catina O'Leary
Medical Writing Special Edition No. 2
February 2020
In a drive for more patient-centric healthcare practices, medical writers are increasingly required to present medical and health information in an easy-to-understand, ‘plain language’ format. The move towards patient engagement and patient involvement in healthcare decisions (‘shared care’) has triggered a raft of new guidances from regulatory authorities.
Medical-Writing-Special-Edition-2-Front-Cover
Truth be Told: Where AI and Automation Can Really Take Us
Julia Forjanic Klapproth
Medical Writing Special Edition No. 2
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
The Clinical Evaluation Report: Bringing it Together
Gerard McGregor
Medical Writing Special Edition No. 2
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Taming the Complexity of Preparing CTD Submission Dossiers
Douglas Fiebig, Johan Telen
Medical Writing Special Edition No. 2
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Implications of Policy 0070 for the Writing of Clinical Dossiers
Julia Forjanic Klapproth, Jo Anne-Marie Blyskal
Medical Writing Special Edition No. 2
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Achieving a Work-Life Balance as Medical Writers
Barry Drees
Medical Writing – A Bold New Path: The Future Awaits Us
February 2020
Medical-Writing-Special-Edition-2-Front-Cover
Medical Writing - A Bold New Path: The Future Awaits Us
Special Edition of International Clinical Trials, ICT
February 2020
CTI2019.2
Lay Summaries and Writing for Patients
Lisa Chamberlain James and Trishna Bharadia
Clinical Trials Insight
Winter 2019
The most recent changes to regulatory legislation in terms of information for patients – the introduction of the lay summary of the risk management plan (RMP) and the lay summary of clinical trial results (CTRs) – have caused great discussion and concern in an industry very willing to provide information to patients, but more used to producing complex scientific information for regulatory authorities (RAs).
Cover-Pharma-Tech-Outlook
Quality-Driven Medical Writing
Stacey Smith
Pharma Tech Outlook, Clinical Trial Management Edition
December 2019
OCT-Handbook-Cover-2020
The Lay Summary – Remember the Reader
Lisa Chamberlain James and Barry Drees
Outsourcing in Clinical Trials Handbook 2020
2020
In 2014, as part of its Clinical Trial Transparency initiative, the EMA mandated a requirement (CTR EU No 536/2014) for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (plain language) no later than one year after the end of the trial in the EU. These CTR lay summaries will be made available in a new EU database; it was planned for 2018, but it is likely that it will not now be implemented before 2020.
emwa-2019
Lay Summaries and Writing for Patients: Where Are We Now and Where Are We Going?
Lisa Chamberlain James and Trishna Bharadia
Medical Writing, the journal of EMWA
Vol. 28 No. 3, September 2019
We examine the trend for increasing and more transparent patient information and ask how close we have come in the last few years to producing useful and meaningful information for patients. We also outline the challenges faced by medical writers and the pharmaceutical industry as a whole in trying to comply with recent European requirements for the creation of lay summaries of key regulatory submission documents.
Generics and Biosimilars
Biosimilar Development – An Overview
Diana Radovan
Medical Writing, the journal of EMWA
Summer 2019
Biosimilars are biological drugs that are similar to, and cheaper than other biological drugs (called “reference originator biologics”) that are already in use. They share an identical amino-acid sequence but, given the inherent variability of biological molecules, not full “sameness”.
MedDevDev
Strategic medical writing for device submissions
Julia Forjanic Klapproth
Medical Device Developments
2019, Volume 1
TOPRA
The challenges of producing periodic benefit–risk evaluation reports
Lisa Chamberlain James and Stephanie Millican
Regulatory Rapporteur
Vol. 16, Issue 5, May 2019
AMWA-journal-232x300
How to Build a Medical Writer: Medical Writing Apprenticeships - New Training for a New Breed
Julia Forjanic Klapproth and Lisa Chamberlain James
AMWA Journal
Vol. 34, No. 2, Summer 2019
Think-Tank-Dossiers-London-2019 (1)
Taming the Complexity of Preparing CTD Submission Documents: Science Meets Logistics
EMWA-Journal-27-4
Help Reviewers Tell You What They Want
Diana Radovan
Medical Writing, the journal of EMWA
Vol. 27 No. 4, December 2018
EMWA-Journal
Getting the most out of quality control specialists: Practical guidance for medical writers
Claire Jones
Medical Writing, the journal of EMWA
Vol. 27, No.3, September 2018
Transparency-requirements-for-clinical-documents-london-2018
Transparency Requirements for Clinical Documents
JCS-Vol-10-Issue-4
Writing Pediatric Study Plans (PSPs) - The Impact of the Revised 2016 FDA Draft Guidance
Diana Radovan and Rachel Beeby
Journal for Clinical Studies
2018 - Volume 10 - Issue 4
medical-device-developments-journal
Getting the Writing Right
Gerard McGregor
Medical Device Developments
2018 - Volume 2
Responses-to-Regulatory-Authorities-think-tank-NC-March-2018
Responses to Regulatory Authorities: Measure Twice - Cut Once
Journal for Clinical Studies FC
The Lay Summary - Remember the Reader
Lisa Chamberlain James and Barry Drees
Journal for Clinical Studies
Dec 2017, Vol. 9, No. 6
As part of its Clinical Trial Transparency initiative, the EMA mandated a requirement for clinical trial sponsors to prepare a summary of the results of every clinical trial written in language understandable to lay persons (patients and others not in the pharmaceutical industry). The regulation (CTR EU No 536/2014) obliges the company to produce this summary of results for the lay audience one year after the end of the trial in the EU.
the-clinical-development-plan-think-tank-Frankfurt-December-2017
The Clinical Development Plan - A Map to Faster and More Successful Approval
PBRERs-and-RMPs-think-tank-london-November-2017
PBRERs and RMPs
Measuring-the-service-of-medical-writing-think-tank-NC-october-2017-
Measuring the Service of Medical Writing
Medical Writing
Regulatory submissions of non-interventional post-authorisation safety studies: Challenges for data interpretation and comparisons with clinical data
James Visanji
Medical Writing, the journal of EMWA
Vol. 26, No. 3, September 2107
WorldPharma-2017-Vol-1-724x1024
You Get What You Give
Julia Forjanic Klapproth
Clinical Trials Insight
Summer 2017
Medical-Writing-Cover-722x1024
The Pharmacovigilance Medical Writer: Medical Writer, Project Manager, Regulatory Expert
Sven Schirp and Lisa Chamberlain James
Special Edition of International Clinical Trials, ICT
February 2017
Medical-Writing-Cover-722x1024
The Challenge of CTD Submissions and Responding to Questions from the Authorities
Douglas Fiebig
Special Edition of International Clinical Trials, ICT
February 2017
Medical-Writing-Cover-722x1024
Medical Writing: The Backbone of Clinical Development
Special Edition of International Clinical Trials, ICT
February 2017
This special edition is meant to increase the general awareness of the need for good documentation on the one hand and to provide good medical writing practices and tricks of the trade on the other hand. It is intended to have lasting value as a reference book for the target audience – medical writers and everyone in the pharmaceutical industry working with medical writers.
Medical-Writing-Cover-722x1024
Streamlining Clinical Study Protocols and Reports
Julia Forjanic Klapproth and Sam Hamilton
Special Edition of International Clinical Trials, ICT
February 2017
Medical-Writing-Cover-722x1024
What you Need and When – The Key Documents in the Drug Lifecycle
Julia Forjanic Klapproth
Special Edition of International Clinical Trials
February 2017
WorldPharma-2016 Vol 2
A New Standard for Medical Writing
Sam Hamilton and Julia Forjanic Klapproth
Clinical Trials Insight
World Pharma 2016 - Vol 2
Measuring-the-Quality-of-medical-writing-think-tank-london-november-2016
Measuring the Quality of Medical Writing
30_Do you measure up_Julia Forjanic Klapproth_EPC_May 2016_Thumbnail
Do You Measure Up?
Julia Forjanic Klapproth
International Clinical Trials, ICT / European Pharmaceutical Contractor, EPC
May 2016
Risk-management-plans-and-summary-for-the-lay-reader-think-tank-Frankfurt-July-2016
Risk Management Plans and Summary for the Lay Reader
29_Back to the future_Douglas Fiebig_MEW 24-3_Sep 2015_Thumbnail
Back to the future... or the amazing lack of progress in effective document review
Douglas Fiebig
Medical Writing, the journal of EMWA
Vol. 24, No. 3, September 2015
Lost in Translation - Data Presentation_Barry Drees_EPC_Sep 2015_Thumbnail
Lost in Translation
Barry Drees
European Pharmaceutical Contractor, EPC
September 2015
Successfully outsourcing medical writing_Julia Forjanic Klapproth_MEW 24-3_Sep 2015_Thumbnail
Successfully outsourcing medical writing
Julia Forjanic Klapproth
Medical Writing, the journal of EMWA
Vol.24, No.3, September 2015
Using social media as the patient's voice_MEW 24-2_Jun 2015_Thumbnail
Using social media as the patient's voice in the benefit-risk assessment of drugs: Are we ready?
Massoud Toussi, Lisa Chamberlain James and Sir Alasdair Breckenridge
Medical Writing, the journal of EMWA
Vol.24, No.2, June 2015
The-Patient’s-Voice-through-social-media
The Patient's Voice Through Social Media
Measuring-the-Quality-of-medical-writing-think-tank-Frankfurt-november-2015
Measuring the Quality of Medical Writing
Good-Pharmacovigilance-Practices-Think-Tank-London-June-2015
Good Pharmacovigilance Practices
Market-Access-and-reimbursement-think-tank-Frankfurt-2015
Market Access and Reimbursement
untitled
The history of The Write Stuff: 10 years of bringing European medical writers together
Barry Drees
The Write Stuff, The journal of EMWA
Vol.17, No.1, 2008
Barry Drees reflects on 10 years as editor of the journal of European Medical Writers Association.
22_Strategic medical writing in the post-authorisation phase_Sarah Richardson_MEW 23-4_Dec 2014_Thumbnail
Strategic Medical Writing in the Post-Authorisation Phase
Sarah Richardson
Medical Writing, The journal of EMWA
Vol.23, No.4, December 2014
The latest legislation for the most common post-authorisation documents (RMP, PSUR, safety studies).
18_Battling with clinical submissions_Julia Forjanic Klapproth_The Write Stuff 15-1_2006_Thumbnail
Battling with clinical submissions: War rooms and other tricks of the trade
Julia Forjanic Klapproth
The Write Stuff, The journal of EMWA
Vol.15, No.1, 2006
Submission dossiers - the most interesting and challenging documents for a medical writer.
14_The Investigator's Brochure_A multidisciplinary document_Douglas Fiebig_MEW 23-2_Jun 2014_Thumbnail
The Investigator's Brochure - A multidisciplinary document
Douglas Fiebig
Medical Writing, The journal of EMWA
Vol.23, No.2, June 2014
The Investigator's Brochure (IB) B is primarily written to enable investigators to assess risks and benefits.
12_Words of Wisdom-Protocol Writing_Julia Forjanic Klapproth_ICT_Aug 2013_Thumbnail
Words of Wisdom: writing Protocols
Julia Forjanic Klapproth
International Clinical Trials, ICT
August 2013
The ABCs of writing effective Clinical Study Protocols
11_Under the Hammer_Julia Forjanic Klapproth & Douglas Fiebig_EPC_Sep 2014_Thumbnail_not big enough_needs 200x280
Under the Hammer
Julia Forjanic Klapproth & Douglas Fiebig
European Pharmaceutical Contractor, EPC
September 2014
Inappropriate use of reverse auctions puts suppliers at an unfair loss and disadvantages buyers.
05_Strategic Benefits_Julia Forjanic Klapproth_ICT_Nov2011_Thumbnail
Strategic Benefits
Julia Forjanic Klapproth
International Clinical Trials, ICT
November 2011
Medical writing helps communicate key messages and makes sure teams stay focused on a common goal.